Assurance, Testing and Auditing for Medical Devices
Sanray provides support for a Medical Device manufacturer’s needs throughout the product life cycle.
Sanray is your go-to Total Quality Assurance partner for everything from Risk Management to Standards Interpretation to Testing and Assurance Execution.
Sanray has been cooperating with Medical Device manufacturers throughout the world to deliver end-to-end assurance solutions, testing, and inspection to help them get to market faster. Sanray Assurance and Consulting services for medical devices are delivered by a separate legal entity’s team of Medical Device Experts, who have no influence over Sanray Notified Body and Certification activities.
Medical Equipment Regulatory Requirements:
Bring your medical device to market with a partner who can help you meet IEC 60601-1, IEC 60601-1-2, MDR, IVDD, and CB Scheme regulatory standards.
Solutions for Medical Device Testing:
Electrical, Electromagnetic Compatibility (EMC), Bluetooth and Wireless Testing, Cyber Security, Software and Mobile Application Testing and Certification for your medical equipment can help you reach your target markets swiftly and cost-effectively.
Certification & Auditing of Medical Management Systems
Integrated compliance solutions and a dedicated, global auditing support network can help you go to market faster, from ISO 13485 to MDSAP.
Services for Scientific Assistance:
All stages of development and manufacture are supported by medical device and materials testing, which includes extractables and leachables as well as bioanalysis.
Research Services in Clinical Practice
Clinical trials for low-risk medical devices conducted by multi-disciplined clinical teams that adhere to GCP and ISO 14155.